Seattle-PAP Bubble Nasal CPAP and Work of Breathing (Seattle-PAP)

A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

The investigators propose to test the hypothesis that Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway pressure.

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia; Respiratory Distress Syndrome In Premature Infants; Newborn Primary Sleep Apnea
• Intervention / Treatment: Device: Seattle-PAP

Detailed Description

The primary outcome variable is work of breathing (WOB) over a two hour period, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles. The following endpoints would also be assessed: Oxygen saturations and Fraction of Inspired Oxygen (FiO2) needed to keep saturations in acceptable ranges, Heart Rates (HR), transcutaneous carbon dioxide (TcPCO2), and respiratory rates throughout the 6 hour study period.

Objective determination of when an infant requires more or less respiratory support is difficult, but measurements of pressure-rate products as estimates of work of breathing, using esophageal catheters, can estimate an infant's respiratory effort. However, objective, simple-to-use, low cost, and non-invasive methods and tools to determine an infant's respiratory effort do not exist currently.

This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 hours to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• infant born less than 32 weeks gestation
• admitted to texas pavilion for women
• between 6 and 72 hours post delivery
• stable on standard bubble nasal CPAP
• informed consent

Exclusion Criteria:

• major congenital anomalies or suspected chromosomal anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.	Device: Seattle-PAP; We propose to test the hypothesis that by introduction of variation in airway pressure Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) reduces work of breathing in very low birth weight infants more effectively than standard bubble nasal continuous positive airway pressure.; Other Names: Sea-PAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work of Breathing	The primary outcome variable is work of breathing (WOB) over three two hour periods, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles.	Six hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Video Recordings of Chest and Abdomen Movements during Breathing	This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.	Six hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
FiO2	Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period.	Six hours
Heart Rates	Heart rates will be assessed during the study period.	Six hours
Transcutaneous Carbon Dioxide Levels	Transcutaneous carbon dioxide (TcPCO2) levels will be assessed.	Six hours
Respiratory Rates	Respiratory rates will be assessed.	Six hours

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Baylor College of Medicine
• Investigators: Study Director: Charles V Smith, PhD, Seattle Children's; Principal Investigator: Stephen E Welty, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: work of breathing; bubble nasal continuous positive airway pressure (Bn-CPAP); pressure-rate products
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Infant, Newborn, Diseases; Sleep Apnea Syndromes; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Sleep Apnea, Central
• Other Study ID Numbers: Seattle-PAP 001